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Our regulatory round-up blogs are now live on our website and will be updated on a monthly basis. If you're struggling to keep on top of regulatory intelligence, this could be a lifesaver. https://lnkd.in/e8KaUiS6 #medicaldevices #regulatory #regulatoryintelligence #blog

A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA) Read more here: https://bit.ly/4aG6VG6 #AgencyIQ #Politico #LifeSciences #FDA #Regulatory #Regulation

Discover how our regulatory services can streamline your path to success: https://lnkd.in/dfwZgQU3 #regulatory #regulatorystrategy #dsiexcellence

📢 Regulatory Intelligence 📢 Regulatory requirements are always evolving, so it is paramount to maintain compliance and stay up to date with changes. Having a robust regulatory intelligence process enables you to stay up to date with all industry news allowing your company and products to remain compliant and on the market for the regions you sell into. Want to know more, check out our Managing Director Laura Friedl-Hirst talk about Regulatory Intelligence in more detail in the video below 👇 Or visit: https://lnkd.in/eZv7828w #regulatoryintelligence #regulatorycompliance #medicaldevcies

Discover how our regulatory services can streamline your path to success! #Regulatory #DSIExcellence

Ensure your product reaches the market swiftly and efficiently with a robust regulatory strategy. Without a well-defined plan, anticipating challenges and meeting crucial submission requirements becomes challenging. Discover how our regulatory services can streamline your path to success: Learn More #RegulatoryStrategy #EfficientMarketEntry #PharmaConsulting

Why being proactive in regulatory compliance is valuable? ↓ In today's rapidly evolving regulatory landscape, proactive compliance has never been more critical, offering numerous benefits: 📈 Market Access: Proactively meeting regulatory requirements ensures seamless market access for your products, allowing you to reach customers and patients efficiently. ⚖️ Risk Mitigation: By staying ahead of regulatory changes and requirements, we mitigate the risk of compliance issues, product recalls, and financial penalties. 🏆 Competitive Advantage: Embracing proactive compliance positions you as an industry leader, instilling confidence in stakeholders and setting you apart from competitors. 🌍 Global Expansion: Compliance with FDA, UKCA, and IVDR standards opens doors to global markets, enabling you to expand your reach and impact. 🤝 Customer Trust: Demonstrating your commitment to regulatory compliance fosters trust and confidence among customers, enhancing your reputation and brand loyalty. We understand the importance of proactive regulatory compliance in today's dynamic regulatory environment. Our experienced team is here to support you every step of the way, from navigating complex regulatory frameworks to ensuring timely compliance with FDA, UKCA, and IVDR requirements. Contact us today to learn how we can help you achieve proactive regulatory compliance: https://lnkd.in/e-237VSD #IVDR #Compliance #regulatoryaffairs #FDA #UKCA #clinicaltrials #biotechnology #IVD #manufacturers

Day 9/10: Adapting to Changes in Global Regulatory Requirements 📝 The Art of Regulatory Affairs: A 10-Day Journey Regulatory requirements are always evolving, from new data standards to updates in safety and efficacy requirements. Staying current with these changes is essential for maintaining compliance and ensuring timely product approvals. In my career, I’ve seen firsthand how important it is to be agile in adapting submission strategies as regulations change across regions. Building a flexible and forward-thinking regulatory team can be the difference between delays and success. How are you keeping up with these shifting regulatory landscapes? 📅 Stay tuned for Day 10 tomorrow! We’ll wrap up by looking at the future of regulatory affairs and what trends we should be prepared for. #RegulatoryUpdates #GlobalCompliance #LifeSciences #AgileStrategy

Regulatory Affairs Professionals Society (RAPS) is seeking regulatory experts to submit proposals for the next #RAPS #RegulatoryIntelligenceConference. If you, a expert skilled in regulatory intelligence, wants to become a speaker, please submit a proposal for a one-hour educational session and/or a one-day preconference workshop. Regulatory professionals supporting the profession! 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐂𝐲𝐜𝐥𝐞: 𝟏𝟔 𝐉𝐮𝐥𝐲 – 𝟐𝟓 𝐀𝐮𝐠𝐮𝐬𝐭 𝟐𝟎𝟐𝟒 𝟏𝟏:𝟓𝟗 𝐏𝐌 𝐄𝐓 See the link here for more information on session type, proposed topics, instructions for submission and cycle schedule: https://lnkd.in/dr6tu7WT #regulataoryintelligence #regulatoryaffairs #networking #conference

The pace of innovation in regulatory affairs doesn't show any signs of slowing down. We asked a few of our #RAPSConvergence 2024 presenters what they think is the biggest trend in regulatory affairs this year. Here’s what they said: https://bit.ly/3LVyhhq